The following data is part of a premarket notification filed by Ssl Americas with the FDA for Durex Male Colored Latex Condoms With Scented Lubricants.
| Device ID | K052959 |
| 510k Number | K052959 |
| Device Name: | DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS |
| Classification | Condom |
| Applicant | SSL AMERICAS 3585 ENGINEERING DR. Norcross, GA 30092 |
| Contact | Chris Robinson |
| Correspondent | Chris Robinson SSL AMERICAS 3585 ENGINEERING DR. Norcross, GA 30092 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-10-21 |
| Decision Date | 2006-01-27 |
| Summary: | summary |